Career Profile
- Accomplished pharmaceutical CMC and Technical Operations executive with board level experience and a proven track record of small molecule drug development from inception to regulatory approval and commercialization.
- Adept at overseeing complex projects from conception to execution, optimizing processes, and ensuring seamless cross-functional collaboration.
- Proven track record of implementing innovative solutions, enhancing efficiency, and achieving cost savings.
- Globally recognized for expertise and deep understanding of CMC, small molecule Process Development, Manufacturing, Scale-up, Quality, Regulatory, Supply Chain Operations, and Strategic Sourcing.
- Experienced leading regulatory filings, IND, NDA, MAA. Subject matter expert, experienced with FDA audits including PAI audits.
- Established leader with a highly professional attitude, high reliability, and high regard for fellow personnel, and committed to empowering, developing and retaining talent.
- Demonstrated success in leadership roles within high-growth companies.
Experience
- Guided a large multi-disciplinary team through the Veltassa development program and commercialization, including process validation, strategic sourcing, regulatory filing and approval (NDA,MAA) in the US and EU, Canada, Australia, Israel and Switzerland.
- Veltassa is a novel polymeric drug developed for the treatment of hyperkalemia.
- Developed world wide supply chain to enable the sourcing of key materials worldwide at multi metric ton scale.
- Led activities to develop and implement a continuous manufacturing process to enhance manufacturing efficiency and lower cost of goods, including engineering and facility design, environmental issues, contract negotiations, as well as interactions with the FDA Emerging Technology (ETT) team.
- Guided a multi-disciplinary team (Process Development, Analytical Development, Sourcing and Supply Chain) through from the initial lab development stages to successful process validation, NDA approval and commercialization for the cabozantinib (Cometriq) small molecule oncology franchise.
- Established the Process Engineering function at Exelixis, recruited talent and led/provided support for several small molecule development compounds in the Exelixis oncology pipeline.
- Led the team through evaluation and outsourcing activities for multiple Exelixis oncology compounds including Cabozantinib.
- Held positions of increasing responsibility in the small molecule process development department. Served as the project leader for two candidates in the BMS p38 program where I led interdisciplinary teams through initial Phase I development activities, scale-up and manufacturing, through to a successful IND filing and subsequent Phase II process development.
- Additionally, held CMC lead roles for several candidates in the BMS PPAR program for the treatment of diabetes, the BMS HMG-CoA program for cholesterol lowering, as well as the BMS CRF-1 antagonist program.
- Senior process engineer for the Onglyza (Saxagliptin) and contributed to the development of Sprycel (Dasatinib) for the treatment of leukemia.
Selected Publications
Sterilization
Processes in the Pharmaceutical Industry - by:
Piero Armenante and Otute Akiti, Chapter in Chemical Engineering in the Pharmaceutical Industry:
Drug Product Design, Development, and Modeling, 2nd Edition, Wiley 2019.
Mixing
and Processes Validation in the Pharmaceutical Industry - by: Otute Akiti and Piero Armenante, Chapter in Advances in Industrial
Mixing: A Companion to the Handbook of Industrial Mixing, Wiley 2015.
Development of a Scaleable Process for the Synthesis of a Next-Generation
Statin -
Lindsay A. Hobson, Otute Akiti, et al, Organic Process Research and
Development, (2010), pp 441-458
Hydrodynamic Effects of Mixing and Competitive Reactions in Laboratory
Reaction Vessels - Otute Akiti, Agnes Yeboah, Ge
Bai and Piero Armenante, Chemical Engineering Science, 60(2005), pp 2341-2354.
Experimentally validated micro-mixing based for fed-batch stirred
reactors - Otute Akiti and Piero M. Armenante,
AIChE Journal, 50(3) , pp 566 – 577
Professional Affiliations
Patents
Crystallization
system using homogenization, International Publication Number: WO 03/095059 A1,
International Publication Date: 20 November, 2003 - by: Otute Akiti and Chenkou Wei.
Crystallization system utilizing atomization, International Publication
Number: WO 03/092852 A1, International Publication Date; 13 November, 2003. -
by: Margaret M. Peel, Otute Akiti and Chenkou Wei.